The present invention relates to instrumentation for the analysis of fluids, and, more particularly, to the fluoropolymer tubing which is used to convey the fluids to, from and within such instrumentation.
Fluid analysis is critical in a wide variety of fields such as, for example, immunology, microbiology, molecular biology and chemistry. In the medical field, in vitro diagnostic testing, is critical in the diagnosis and treatment of disease and patient management. Medical uses for in vitro diagnostic testing may include diagnosis, screening, therapeutic drug monitoring, collecting epidemiological information, monitoring a course of disease, and antimicrobial susceptibility testing. Reliability is essential because the failure of in vitro diagnostic testing may result in misdiagnosis and incorrect, insufficient, unnecessary, or delayed treatment. The consequences to the patient may be serious or life threatening, depending on various factors including the patient's condition and the clinical significance of the diagnostic test. In vitro diagnostic reagents and systems include those used in hospitals, clinical laboratories, satellite medical facilities, physician's offices, pharmacies, and in the home by consumers.
The availability of sensitive instrumentation for fluid analysis continues to improve. Nonetheless, the accuracy of such instrumentation is dependent upon accurate volume and/or reagent concentration detection which in turn requires the reliable detection of bubbles in the analyte or reagent fluid stream being analyzed. Over time, testing volumes have increased and the machines used for such analysis have gotten faster and more sophisticated. The increased speed of the machines means that fluids are being moved faster and faster. This in turn affects fluid dynamics and the fluids being analyzed are increasingly susceptible to breaking up at the higher speeds. This fluid break up affects accurate volume and/or reagent concentration confirmation.
In addition, fluid analysis testing has become increasingly sophisticated. In the medical field, for example, it is not uncommon to perform over 90 tests on a blood sample and to require the use of 2-4 reagents in such tests. Each test may require up to 2-4 fluid additions. One probe of a fluid analysis machine may be exposed to over 240 different fluid compositions related to a given blood sample. It is imperative that the different fluid streams being analyzed do not affect each other where a large range of fluid compositions are being analyzed. The increased speed and test volumes involved with fluid analysis have led to increased volume and reagent concentration check errors and volume check errors can require over 50% of fluid analysis tests to be repeated. Repeat analyses require greater analysis time, less efficiency and increased cost. The greater analysis time may be particularly critical in medical situations where treatment decisions are based on the results of in vitro diagnostic testing.
Thus there is a need to minimize the errors involved in the confirmation of fluid volumes and reagent concentrations in analytic instrumentation.